Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial

In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.

Study Overview

• Status: Completed
• Conditions: Time Restricted Feeding; Non-Alcoholic Fatty Liver Disease; Mobile Technology
• Intervention / Treatment: Behavioral: Mobile application and wearable device; Behavioral: Time-restricted eating

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 133792
    • Hanyang University Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged ≥ 19 years who are willing and able to complete all procedures
• Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 dB/m))

Exclusion Criteria:

• Body mass index (BMI) <23
• Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chronic cholestatic liver disease
• Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)
• Significant alcohol intake (>210g/week for men, >140g/week for women)
• Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure > 200/120 mmHg)
• Psychiatric illnesses which limit ability to exercise safely
• Diagnosed with diabetes on medication or insulin
• Participation in a weight-loss program within 12 weeks
• MRI contraindications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE); This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of both calorie restriction (500kcal below estimated energy requirement) and time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day).	Behavioral: Mobile application and wearable device; Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity; Behavioral: Time-restricted eating; Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)
Active Comparator: Mobile application-supported calorie restriction (mCR); This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of only calorie restriction (500kcal below estimated energy requirement).	Behavioral: Mobile application and wearable device; Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
No Intervention: Calorie restriction (CR); Standard of care. This arm receives a brief counseling of calorie restriction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hepatic steatosis (%)	Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk	Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)	16 weeks
Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)	Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver	16 weeks
Change in body weight (kg)	Evaluate the mean change in body weight (kg)	16 weeks
Change in systolic blood pressure (mmHg)	Evaluate the mean change in systolic blood pressure (mmHg)	16 weeks
Change in low-density lipoprotein level (mg/dL)	Evaluate the mean change in low-density lipoprotein level (mg/dL)	16 weeks
Change in serum alanine aminotransferase level (IU/L)	Evaluate the mean change in serum alanine aminotransferase level (IU/L)	16 weeks
Change in hemoglobin A1c level (%)	Evaluate the mean change in hemoglobin A1c level (%)	16 weeks
Change in insulin sensitivity	Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)	16 weeks
Change in urine microalbumin (mcg/min)	Evaluate the mean change in urine microalbumin (mcg/min)	16 weeks
Change in liver fibrosis by liver stiffness (kPa)	Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®	16 weeks
Change in liver steatosis by controlled attenuation parameter (dB/m)	Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®	16 weeks
Change in body muscle mass (kg)	Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)	16 weeks
Change in body weight (kg) at 6 months after the intervention	Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period	40 weeks
Change in body weight (kg) at 12 months after the intervention	Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period	64 weeks

Collaborators and Investigators

• Sponsor: Hanyang University
• Collaborators: National Institute of Health, Korea
• Investigators: Study Chair: Dae Won Jun, M.D., Ph.D., Hanyang University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 12, 2024

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HanyangU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No